DLTs and SAEs

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DLTs and SAEs

by robertmiles1 on Fri Feb 03, 2012 03:44 PM

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In Phase I oncology trials, should all DLTs be SAEs?. Do you consider any situation where a toxicity is significant enough (normally grade 3 or 4 except some particular cases) to be a DLT but without qualifying for SAE (no death, no hospitalization... no medically significant)?

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